CARDIOLAB AMPLIFIER MODULE (CAM)
Device Facts
| Record ID | K910307 |
|---|---|
| Device Name | CARDIOLAB AMPLIFIER MODULE (CAM) |
| Applicant | Prucka Engineering, Inc. |
| Product Code | DRR · Cardiovascular |
| Decision Date | Apr 12, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2050 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A biopotential amplifier and signal conditioner is a device used to amplify or condition an electrical signal of biologic origin.
